1.00383
DL-苹果酸
EMPROVE® ESSENTIAL, Ph. Eur., NF, FCC, E 296
别名:
DL-Malic acid, DL-Hydroxysuccinic acid, Hydroxybutanedioic acid
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关于此项目
经验公式（希尔记法）:
C4H6O5
化学文摘社编号:
分子量:
134.09
UNSPSC Code:
12352106
E Number:
E296
EC Index Number:
230-022-8
MDL number:
SMILES string
[O-]C(=O)C(O)CC(=O)[O-].[H+].[H+]
InChI
1S/C4H6O5/c5-2(4(8)9)1-3(6)7/h2,5H,1H2,(H,6,7)(H,8,9)
InChI key
BJEPYKJPYRNKOW-UHFFFAOYSA-N
agency
NF, Ph. Eur.
reg. compliance
FCC
product line
EMPROVE® ESSENTIAL
form
solid
autoignition temp.
349 °C
potency
>3200 mg/kg LD50, oral (Rat)
technique(s)
API processing | cocrystal formation: suitable, API processing | salt formation: suitable
pH
2.3 (20 °C, 10 g/L in H2O)
mp
128-132 °C
transition temp
flash point 203 °C
solubility
558 g/L
density
1.60 g/cm3 at 20 °C
application(s)
pharmaceutical
solid formulation
storage temp.
15-25°C
Quality Level
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General description
Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our EMPROVE® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.
As part of our EMPROVE® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.
Application
Malic acid is typically applied as acidulant and pH adjuster as well as taste modifier in pharmaceutical formulations and food. In addition, it has antioxidant properties.
DL-Malic acid Emprove® Essential is mainly used in highly regulated pharmaceutical applications.
DL-Malic acid Emprove® Essential is mainly used in highly regulated pharmaceutical applications.
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
signalword
Warning
hcodes
Hazard Classifications
Eye Irrit. 2
存储类别
11 - Combustible Solids
wgk
WGK 1
flash_point_f
397.4 °F
flash_point_c
203 °C
商品
Instead of addressing API solubility during formulation, tackle it early during development. Read about the various methods for API processing.
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